Ask a Pharmacist: What do federal EPCS mandates mean for me?

By Meg Flynn, PharmD and Clinical Workflow Specialist at Imprivata

From the clinician to the pharmacist to the patient, there are many questions about what federal EPCS mandates could mean for public health. Drawing on her professional experience, PharmD Meg Flynn helps us answer some of those questions.

General Questions

  1. Can you briefly explain what EPCS is and why it exists?
    • EPCS stands for the electronic prescribing of controlled substances (CS)
    • It is a means of sending a prescription to the pharmacy in an electronic format instead of paper.
    • This creates a digital record of the prescription sent from the prescriber to the pharmacy, ensures certain regulatory fields are completed, and requires a DEA-compliant electronic signature by the prescriber.
  2. How do federal EPCS mandates differ from state EPCS mandates?
    • As of 1/1/22, 34 states have EPCS requirements, and 3 states have regulations that will go into effect in 2023
    • The current federal EPCS mandate is for CS filled for Medicare Part D recipients
      • The new legislation being proposed in EPCS 2.0 will be for all CS paid for by all payers, including private insurance
    • State mandates typically apply to all CS regardless of payer status (Medicare/Medicaid/private/cash) or even for the e-prescribing of all medications in any schedule
      • State mandates are generally more strict than federal
  3. What issues do you project will arise from federal EPCS mandates?
    • People don’t like change, that’s just human nature
      • Initially, people throw up their hands when they’re forced to do something unfamiliar, but I think that the pandemic has primed everyone in healthcare for a shift to electronic means
    • Pharmacist and prescribers went through the growing pains of EPCS mandates when their state mandate came into effect, and for many, that was before the initial EPCS mandate. Now that there already is one federal EPCS mandate, I have yet to encounter a provider who has truly made the distinction between sending a CS prescription to the pharmacy for a Medicare versus a private insurance paying patient. Once the initial lift to get EPCS up and running is off the floor, they're running with it for all CS prescriptions, if not all prescriptions in general.
      • I worked in New York, the first state to mandate EPCS (and all prescriptions), only a year into their mandate going into effect. There were growing pains with prescribers learning how to use the technology, patients not knowing if they still needed to pick up a paper prescription from the office, and pharmacists navigating the complexities of how to get patients their medication if there was a technology hiccup. However, those issues resolved themselves in time, and everyone adjusted.
    • Rural communities might feel the most pressure, since their hospitals might still be using pen and paper charting and prescribing due to financial constraints or lacking internet connectivity
      • There are waivers for such circumstances, financial or technical conditions, that will allow for prescribers to continue to write paper prescriptions for their patients if there is financial hardship caused by adopting EPCS or is simply no internet available
      • I worked in one of these communities during my time in Upstate NY, and I encountered these waivers frequently. It didn’t prohibit a patient from getting their medications
  4. How could federal EPCS mandates benefit public health or help reduce drug diversion/addiction?
    • No more stolen prescription pads.
      • Since EPCS is so widely used and theft of prescription pads has been such an issue in the past, every paper prescription is scrutinized. There are even regulations in some states that require a call to the prescriber to validate that they did indeed write the prescription.
    • No more duplicative prescriptions dropped off to multiple pharmacies to ensure that the patient doesn’t have to go back and forth to the doctor when one pharmacy cannot fill the prescription but needs to keep it on file in order to fulfil once the drug is available
      • I’ve encountered patients filling the same prescription 3 times in the same day at different chains if they were paying cash
      • Sometimes it’s for self-use, but others it’s to sell or give to others
  5. How will compliance be measured/enforced?
    • The responsibility will fall on the providers, who would theoretically be penalized monetarily by insurers, but that’s not yet being enforced
  6. Who is eligible for an EPCS waiver? And what does that mean exactly?
    • A waiver is granted to a facility that would be substantially financially burdened by implementing an EPCS solution or those in rural areas without internet access
    • A waiver either extends the amount of time they must implement a solution or internet
      • That timeframe varies depending on circumstances
  7. What will happen to hospitals/pharmacies that are not compliant?
    • That is still unknown
  8. Does this require implementing new technology?
    • To many institutions, no. Because EPCS mandates at the state level have already been in place for many years and there is already one federal mandate, most already have EPCS capabilities.

Questions About EPCS in Your Local Pharmacy

  1. What was your personal experience like with achieving EPCS mandates when you worked as a pharmacist?
    • It causes frustration in the early days of the mandate, as any change does.
      • Older generations of pharmacists/prescribers/patients like holding a physical paper prescription because it’s what they’re used to.
    • Then, there is the convenience factor that people realize benefits them.
      • The patient no longer needs to drive to the doctor's office to pick up a prescription, the doctor can potentially prescribe from their home or after hours to help their patients, and the pharmacy doesn’t need to call a doctor up and take up everyone’s time reading illegible handwriting or verifying if the script is legitimate.
      • Once this is realized and the initial technical hurdles are overcome, everyone comes around
    • The most difficult aspect is accountability. If a pharmacy continues to accept paper, the doctor continues to write paper, and the patient doesn’t realize there is any mandate. Then, when the pharmacy or doctor changes their method abruptly because they’ve been told to by a governing body, the patient is the one who suffers because their medication being filled is delayed.
  2. What are the biggest challenges commercial and local pharmacies will face when trying to meet EPCS mandates?
    • The technology hurdles for any prescribers who are new to EPCS. Sometimes they forget to do their final sign off, and the pharmacy doesn’t receive the script. Or, sometimes there are glitches that need to be worked through, which can delay a script getting to the pharmacy quickly
    • Expectations of patients. They think that electronic means instantaneous, but that’s not true. While the prescription might be in a queue to be sent to the pharmacy, the doctor needs to officially “sign off” electronically for it to transmit. This creates frustration when a patient leaves their doctor’s office expecting the script to be filled already when it hasn’t even arrived.
  3. Who will feel the biggest impact of EPCS mandates? Why/how? For better or for worse? Ex: the pharmacist, patient, insurer, etc.
    • Everyone will feel it differently but will be impacted. See above explanations
  4. What will pharmacists need to change under this new mandate?
    • This new mandate explicitly calls out that the pharmacy will not be required to enforce EPCS nor will they be required to obtain a record of a waiver.
    • However, unless that is made clear, some pharmacists might think it is their duty to enforce the policy and will do so. This could be burdensome to the patient if there are time constraints to filling their script.
  5. What are the benefits of EPCS for both commercial and local pharmacies?
    • Once everyone is used to it, it’s easier for everyone.
    • Quicker time to process the prescription at the pharmacy because many fields are auto-populated from the e-rx, there is no scanning of paper or trying to make out someone’s handwriting.
    • No more calling a doctor, being transferred multiple times, being left on hold, leaving a message, and then calling back a couple more times to get a response to make sure you’re interpreting the correct name/dosage/instructions. It’s a huge time commitment for everyone involved just to make sure a 15 isn’t a 25, for example.

Questions about EPCS in Hospitals:

  1. In short, what will federal EPCS mandates mean for states that do not have mandates in place? What about those that do have state mandates?
    • For states that do have mandates, generally, there will be no change as most states have more stringent regulations
    • For states without mandates, there already is one federal mandate, which prompted most institutions nationwide to implement EPCS already. The only group who might not have implemented EPCS yet are non-Medicare participating providers and/or rural community providers (who would likely still be able to obtain a waiver)
  2. Is there a way that EPCS could be met that negatively impacts clinician/provider workflows? What would this look like?
    • If the EPCS solution is not working, this would impact workflows. However, there are exceptions to technical failures that would allow for paper prescriptions to be used during downtime. This is cumbersome once workflow via EPCS is established, but tech glitches happen.
  3. Could you describe how the system/workflow will change for hospitals that need to meet EPCS?
    • Providers will need to meet DEA requirements for MFA to write and sign off on a controlled substance prescription. This would require enrollment on an institutional or individual basis, but either way, each prescriber needs to meet these requirements.
  4. What is the best way to meet EPCS without hindering clinician workflows? Is there a specific access/authentication method that works well?
    • Giving providers a variety of modalities for signing off on a CS prescription, such as a fingerprint scanner and soft token, can allow for quick authentication and signing capabilities. Also, remote access can allow them to prescribe at their kid’s soccer game or when they’re off for the day, which makes their patients happy and their lives easier.

Questions about EPCS from the Patient:

  1. Will these mandates make it harder to get the medication I need?
    • It should make it easier. So long as the prescription is signed off on and sent electronically, the prescription is much easier to process at the pharmacy.
    • If the pharmacy is out of stock, the doctor can also quickly re-send for a new drug or dosage instead of having to drive back to the office to get a paper copy. CII drugs, like oxycodone for example, cannot be taken over the phone, so patients would need to go back and forth to pick up a new scrip pre-EPCS.
    • The one caveat I have encountered is that a lot of doctors batch sign off on CS prescriptions at certain times, usually the end of their shift, and that can cause delays. My remedy for that has always been to advise patients to call ahead for their prescriptions, and the pharmacy can keep the script on record to be filled when it’s due instead of waiting until the day of and maybe getting it after a missed dose.